Sofregen Medical Inc. in Medford, Massachusetts receives FDA inspection

Sofregen Medical Inc. in Medford, Massachusetts was inspected by the Food and Drug Administration (FDA) on July 31 for device compliance and received one citation, according to data posted on the FDA’s official website.

The FDA website shows that the company was cited for the following problem: 'A device master record has not been adequately maintained.'

The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.

The FDA is a government agency that is primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

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